NCT02768155已完成不适用
Protocol for the Clinical Evaluation Amniotic Fluid (AF) Product in Knee Osteoarthritis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Reduction in Pain
研究概览
简要总结
A study evaluating Amniotic Fluid compared to a Saline Placebo Injection in the treatment of subjects with osteoarthritic (OA) knee pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 30 years or older.
- •Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale.
- •Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study.
排除标准
- •Subject has active infection at the injection site.
- •Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other auto-immune disorders that could be the cause of their knee pain.
- •BMI greater than 45 kg/m2
- •Subject has received an intra-articular hyaluronic acid (HA) injection for the treatment of OA of the target knee within 3 months prior to screening.
- •Subject has received a steroid or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 3 months prior to screening.
- •Subject has had major surgery, arthroplasty or arthroscopy in the target knee within 26 weeks of treatment or plans to have surgery in the target knee within 180 days of treatment.
- •Subject is pregnant or plans to become pregnant within 180 days of treatment.
- •Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment.
- •Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation.
- •Subject has a history of immunosuppressive or chemotherapy in the last 5 years
- •Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
- •Subject has had prior radiation at the site
- •Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
- •Diagnosis of gout in the past 6 month
- •Subject has a diagnosis of osteoarthritis
研究组 & 干预措施
AF 4.0
Experimental
Amniotic Fluid 4.0ml dose
干预措施: Amniotic Fluid 4.0ml dose (Other)
AF 2.0
Experimental
Amniotic Fluid 2.0ml dose
干预措施: Amniotic Fluid 2.0ml dose (Other)
Placebo
Placebo Comparator
Saline Placebo Control
干预措施: Placebo Control (Other)
结局指标
主要结局
Reduction in Pain
时间窗: 3 months
次要结局
- Range of Motion(3 month)
- Knee injury and Osteoarthritis Outcome Score (KOOS)(3 month)
- WOMAC(3 month)
- Kellgren-Lawrence grade of OA(6 months)
研究者
研究点 (4)
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